NINDS ADMINISTRATIVE SUPPLEMENTS:
OVERCOMING BARRIERS TO NEUROLOGICAL THERAPEUTICS DEVELOPMENT
RELEASE DATE: October 30, 2003
NOTICE: NOT-NS-04-001
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
The National Institute of Neurological Disorders and Stroke (NINDS)
announces an administrative supplement program of up to $1 million in
fiscal year 2004 to promote progress in pre-clinical neurological
therapeutics development. This administrative supplement program is
issued in response to recommendations from the NINDS Strategic Plan
(http://www.ninds.nih.gov/about_ninds/plans/strategic_plan.htm). The program
is intended to facilitate the identification of new treatments for
neurological disorders from candidate therapies identified or evaluated
in ongoing, peer-reviewed projects. Principal Investigators with
Research Project (R01), Exploratory/Development (R21), Phase II SBIR
(R44), Program Project (P01), Specialized Center (P50 or U54), and
Cooperative Agreement (U01) grants funded by NINDS are eligible to
apply.
The goal of this program is to open critical paths in pre-clinical
therapeutics development by funding small, focused projects. Supported
studies should be designed to demonstrate the promise of therapies to
1) reduce the barriers to commercial development or 2) justify NIH
funding for additional pre-clinical or clinical development. Thus,
proposals should demonstrate both a sound rationale for the proposed
project and a feasible plan to support further development of the
candidate therapy. The proposed intervention(s) should have clearly
demonstrated promise as treatments for neurological disease based on
data from previous in vitro, animal or clinical testing. Highest
funding priority will be given to studies that are specifically
designed to support an IND application for clinical testing, and that
form part of a well-developed plan for pursuing an IND.
Examples of studies to be funded under this program include:
o Studies to test the efficacy of highly promising interventions in
animal disease models
o Pre-clinical safety, kinetic or metabolic studies of strongly
supported therapeutic leads
o Chemical optimization of strongly supported therapeutic leads
o Screening of clinically approved drug collections in neurological
models
Studies that are not encouraged under this announcement include early
stage exploratory studies, such as model development or target
validation. Clinical studies will not be supported under this
announcement.
It is acceptable to purchase commercial or institutional services to
conduct the proposed studies. Requests for salary may be included, in
proportion to time directly devoted to the supplemental project.
Evidence should be presented that the results of the supplemental
assistance will enhance the pursuit of the Specific Aims of the
original research project, without constituting an expansion of scope.
Supplements are one-time awards and will not extend to subsequent
budget periods.
HOW TO APPLY
Applicants should submit an original and five complete copies to Dr.
Jill Heemskerk at the address listed at the end of this notice. The
following sections should be included:
1. A cover page citing this NOTICE and including the following
information: PI name, grant number and title, direct and indirect costs
requested, name and title of the institutional official, and phone,
email, and address information for both the PI and institutional
official. Document the approval from the Institutional Animal Care and
Use Committee (IACUC) for any animal testing. For P01s and P50s and
U54s, the named PI must submit a request for a supplement to a
subproject. THIS COVER PAGE MUST BE SIGNED BY AN AUTHORIZED
INSTITUTIONAL OFFICIAL.
2. A description of the project (5-page limit), including:
o an abstract
o a rationale for the candidate therapeutic
o the design of the proposed study
o the plans for further development following the supplemental study
The applicant should describe the relationship of the project to the
Specific Aims of the parent grant. Evidence should be presented that
the results of the supplemental assistance will enhance the pursuit of
the Specific Aims of the original research project without constituting
an expansion of scope.
o human subjects
o vertebrate animals
If research involving human subjects or vertebrate animals was
previously approved as within the scope of the project, then include
the corresponding information as in the PHS 398 Research Plan, sections
e. Human Subjects and/or f. Vertebrate Animals for the supplemental
project. If human subjects and/or vertebrate animals were not
previously approved, they cannot be added through this administrative
supplement.
3. A modular budget with appropriate justifications for requested
direct costs and specifying Facilities and Administrative Costs.
4. Specific Aims of the original grant.
POST-AWARD REQUIREMENTS
A one-page report that specifically addresses the results of the
supplement will be required. It should be included as an addition to
the progress report of the parent grant, submitted the year following
the supplement award.
REVIEW CRITERIA
Applications will be reviewed administratively, and it is expected that
a resulting Supplemental Notice of Grant Award will be issued within
four months of the receipt deadline. All funding decisions are final
and are not subject to appeal.
Review criteria will include:
o the quality of the rationale for the candidate therapy
o the scientific merit of the study design
o the feasibility of the plans for further development following
supplemental study
o importance of the study in moving the candidate therapy toward the
clinic
BUDGET INFORMATION
Supplements will be awarded as direct costs in modular amounts of
$10,000 and are one-time awards. Any Facilities and Administrative
(indirect) Costs should also be specified in the budget request. For
R01s, R21s, and R44s, the maximum request for direct costs is $50,000.
For P01s, P50s, U54s, and U01s, the maximum is $100,000. Although the
awarded budgets will be modular, applicants should provide a budget
justification that details the budget items requested, including
Facilities and Administrative costs. If the planned study will not be
fully supported by the supplemental funds from NINDS, the sources and
amounts of additional funds should be specified.
NINDS will commit $1 million in total costs to fund applications for
supplements submitted in response to this Notice. Awards pursuant to
this Notice are contingent upon the availability of funds and the
receipt of a sufficient number of applications of high scientific
merit.
Receipt dates: January 30, 2004 April 30, 2004
Earliest Award date: April 30, 2004 July 30, 2004
INQUIRIES
Direct inquiries regarding the program to:
Dr. Jill Heemskerk
Technology Development Group
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd. NSC Room 2229
Bethesda, MD 20892 (USPS)
Rockville, MD 20852 (FedEx and other couriers)
Tel: (301) 496-1779
Fax: (301) 402-1501
Email: jill_heemskerk@ninds.nih.gov
Direct inquiries regarding fiscal matters to:
Ken Bond
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., NSC Room 3246
Bethesda, Maryland 20892 (USPS)
Rockville, MD 20852 (FedEx and other couriers)
Tel: 301-496-9231
Fax: 301-402-0219
Email: bondk@ninds.nih.gov